AFT SYSTEM III

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

CALBIOCHEM-BEHRING CORP.

The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Aft System Iii.

Pre-market Notification Details

Device IDK830214
510k NumberK830214
Device Name:AFT SYSTEM III
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-24
Decision Date1983-03-09

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